Coated beta hydroxybutyric acid crystal and methods for producing the same

Abstract

Coated beta-hydroxybutyrate (BHB) free acid crystal pellets/granules are provided, which comprise BHB free acid crystal, fillers, and coating material. Methods for producing coated BHB free acid crystal pellets/granules are provided, which may include (a) wet granulation, (b) extrusion, (c) spheronization, and (d) coating, such as coating material spray embedding through Wurster bottom spray coating device.

What is claimed is: 
     
         1 . A coated beta-hydroxybutyrate (BHB) free acid crystal pellet/granule, comprising a BHB free acid crystal, a filler, and a coating material, wherein the coated BHB free acid crystal pellets/granules are made of raw materials comprising (a) the BHB free acid crystal with a mass percentage ranging from 10.00% to 99.00%; (b) the filler with a mass percentage ranging from 1.00% to 60.00%; and (c) the coating material with a mass percentage ranging from 0.10% to 80.00%. 
     
     
         2 . The coated BHB free acid crystal pellet/granule of  claim 1 , wherein the coated BHB free acid crystal pellets/granules are made of raw materials comprising (a) the BHB free acid crystal with a mass percentage ranging from 50.00% to 95.00%; (b) the filler with a mass percentage ranging from 1.00% to 30.00%; and (c) the coating material with a mass percentage ranging from 1.00% to 45.00%. 
     
     
         3 . The coated BHB free acid crystal pellet/granule of  claim 1 , wherein the BHB free acid crystal comprises D-BHB, DL-BHB, and L-BHB forms or a mixture thereof. 
     
     
         4 . The coated BHB free acid crystal pellet/granule of  claim 1 , wherein the filler comprises microcrystalline cellulose, lactose, mannitol, starch, sodium starch octenyl succinate, pregelatinized starch, sodium carboxymethyl cellulose, sodium carboxymethyl starch, cross-linked sodium carboxymethyl starch, resistant dextrin, methyl cellulose, hydroxypropyl methyl cellulose, hydroxyethyl cellulose, β-cyclodextrin, or a mixture thereof. 
     
     
         5 . The coated BHB free acid crystal pellet/granule of  claim 1 , wherein the coating material comprises hydroxypropyl methyl cellulose, carrageenan, xanthan gum, gum arabic, modified starch, polyvinyl alcohol, titanium dioxide, talc, triacetin, pigments, or a mixture thereof. 
     
     
         6 . The coated BHB free acid crystal pellet/granule of  claim 1 , wherein the coated BHB free acid crystal pellet/granule has a particle size ranging from 10 to 80 mesh. 
     
     
         7 . A composition for promoting and/or sustaining ketosis in a mammal, comprising a coated BHB free acid crystal pellet/granule of  claim 1 . 
     
     
         8 . A method for preparing coated BHB free acid crystal pellets/granules, comprising (a) wet granulation, (b) extrusion, (c) spheronization, and (d) coating, wherein the wet granulation step comprises: mixing a BHB free acid crystal and a filler;
 and adding a binder solution to obtain a wet material.   
     
     
         9 . The method of  claim 8 , wherein the coating step comprises coating material spray embedding through Wurster bottom spray coating device. 
     
     
         10 . The method of  claim 8 , wherein the mixing ratio of the BHB free acid crystal and the filler ranges from 99:1 to 40:60 (weight by weight or volume by volume); and/or the ratio of the filler and binder solution ranges from 1:1 to 1:1.5 (weight by weight or volume by volume). 
     
     
         11 . The method of  claim 8 , wherein the extrusion step comprises extruding the wet material obtained in step (a) by an extruder, to obtain a strip material with the same diameter. 
     
     
         12 . The method of  claim 8 , wherein the spheronization step comprises:
 sphering the strip materials obtained in step (b) at a high speed through a spheronization device to obtain pellets/granules with the same size and desired roundness.   
     
     
         13 . The method of  claim 8 , wherein the drying step comprising: drying the pellets/granules prepared in step (c) to obtain BHB free acid crystal pellets/granules. 
     
     
         14 . The method of  claim 13 , wherein moisture content of final material is controlled below 5%. 
     
     
         15 . The method of  claim 8 , wherein the coating step comprising: coating the BHB free acid crystal pellets/granules prepared in step (d) with a coating material by a Wurster coater. 
     
     
         16 . The method of  claim 15 , wherein the coated BHB free acid crystal pellets/granules have a particle size ranging from 10 to 80 mesh. 
     
     
         17 . The method of  claim 8 , wherein the filler comprises microcrystalline cellulose, lactose, mannitol, starch, sodium starch octenyl succinate, pregelatinized starch, sodium carboxymethyl cellulose, sodium carboxymethyl starch, cross-linked sodium carboxymethyl starch, resistant dextrin, methyl cellulose, hydroxypropyl methyl cellulose, hydroxyethyl cellulose, B-cyclodextrin, or a mixture thereof. 
     
     
         18 . The method of  claim 15 , wherein the coating material comprises hydroxypropyl methyl cellulose, carrageenan, xanthan gum, gum arabic, modified starch, polyvinyl alcohol, titanium dioxide, talc, triacetin, pigments, or a mixture thereof. 
     
     
         19 . A method for preparing coated BHB free acid crystal pellets/granules, comprising (a) wet granulation, (b) extrusion, (c) spheronization, and (d) coating, wherein the wet granulation step comprises: mixing a BHB free acid crystal and a filler; and adding a binder solution to obtain a wet material, wherein the mixing ratio of the BHB free acid crystal and the filler ranges from 99:1 to 40:60 (weight by weight or volume by volume).